Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04512781
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2020-08-06
Brief Title:
Clinical Efficacy in Relief of Dyspnea by HVNI Evaluation of New Cannulae Designs
Sponsor:
Vapotherm Inc
Organization:
Vapotherm Inc
Study Overview
Official Title:
Clinical Efficacy in Relief of Dyspnea by HVNI Evaluation of New Cannulae Designs
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the ability of High Velocity Nasal Insufflation HVNI next generation nasal cannula designs to effect ventilation and related physiological responses relative to the conventional legacy cannula design
Detailed Description:
The objective of this study is to evaluate the ability of HVNI next generation nasal cannula designs to effect ventilation and related physiological responses relative to the current cannula design with which there are published clinical outcomes data It is hypothesized that next generation nasal cannula designs Prosoft and Unicorn will be comparable at relieving patient dyspnea while on HVNI when compared to the conventional Legacy cannula
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None